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Minocycline and Tobacco Craving in Smokers With Schizophrenia

Primary Purpose

Schizophrenia, Tobacco Use

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Minocycline
Placebo
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • DSM-IV or DSM-5 diagnosis of schizophrenia or schizoaffective disorder
  • Male or Female
  • Age: 18 to 65 years
  • Caucasian or Non-Caucasian
  • Smoke at least 10 cigarettes daily
  • Urine cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3)
  • Agrees to wear a head mounted display (HMD) for up to 45 minutes
  • Able to complete the Evaluation to Sign Consent (ESC) with minimum score of 80%

Exclusion Criteria

  • History of organic brain disease
  • DSM-IV diagnosis of Alcohol or Substance Dependence within the last six months (except nicotine) or DSM-5 diagnosis of Substance Use Disorder in the last six months (except nicotine)
  • DSM-IV diagnosis of Alcohol or Substance Abuse within the last one month (except nicotine) or DSM-5 diagnosis of Substance Use Disorder in the last six months (except nicotine)
  • Pregnancy or lactation
  • Severe liver dysfunction (LFT 3X upper limit of normal)
  • Previous known hypersensitivity to tetracyclines
  • Current treatment with tetracycline or derivative
  • Treatment with oral contraceptives (unless a second form of birth control is used and documented)
  • Treatment with cholestyramine or colestipol
  • Treatment with Urinary alkalinizers (e.g., sodium lactate, potassium citrate)
  • Treatment with warfarin
  • Treatment with bupropion, varenicline, or nicotine replacement products in the month prior to study inclusion
  • Less than two months treatment of adjunctive medications AND less than one month on same dose: beta blockers, antidepressants, mood stabilizers, antianxiety medications.
  • Medical condition whose pathology or treatment would significantly increase the risk associated with the proposed protocol.
  • History of head injury, seizures, or stroke
  • Positive urine toxicology screen for substances of non-therapeutic use prior to craving assessments

Sites / Locations

  • Maryland Psyciatric Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Minocycline

Placebo

Arm Description

Participants will take 50 mg minocycline capsules twice daily for 1 week, then take 100 mg capsules twice daily for 1 week.

Participants will take capsules that match active drug, but contain no active ingredients, twice daily for week 1, and then will take capsules that match active drug, but contain no active ingredients, twice daily for week 2.

Outcomes

Primary Outcome Measures

Questionnaire for Smoking Urges-Brief
This is a 10-item assessment used to measure craving to smoke and used in studies of smokers with schizophrenia. This scale has a score range from 0-100The change in QSU-Brief craving scores between time points (baseline to week 1, and baseline to week 2) will be assessed. The change in scores between the two timepoints will be calculated. The higher the score the stronger the urge to smoke is.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2016
Last Updated
January 4, 2022
Sponsor
University of Maryland, Baltimore
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02968602
Brief Title
Minocycline and Tobacco Craving in Smokers With Schizophrenia
Official Title
Minocycline and Tobacco Craving in Smokers With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 31, 2017 (Actual)
Primary Completion Date
July 23, 2019 (Actual)
Study Completion Date
July 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Craving for cigarettes is an important aspect that leads to challenges with smoking cessation. Persons with schizophrenia are more likely to smoke and to be heavier smokers than persons without schizophrenia, and may experience craving differently as well. Minocycline is an antibiotic medication that may impact craving. We will conduct a two-week randomized, double-blind, placebo-controlled, parallel group pilot study to investigate the effects of minocycline vs. placebo on craving and smoking behaviors in smokers with schizophrenia. Participants will take minocycline or matching placebo for two weeks. Participants will be assessed on aspects of craving and smoking behavior at baseline and after 1 and 2 weeks of minocycline or placebo treatment.
Detailed Description
Nicotine dependence is high in schizophrenia; nearly three times more prevalent than the general population. In smokers with schizophrenia, the risk of all-cause mortality is doubled and cardiovascular mortality risk is twelvefold higher than nonsmokers. Many factors influence smoking in persons with schizophrenia, but predictors of craving and smoking behavior are not well established. Craving is a major contributor to smoking behaviors, and, importantly, is a predictor of relapse risk. Since craving may precede relapse, it can be advantageous as a screening tool for those attempting cessation. In addition, focusing on treatments aimed to reduce craving may lead to better therapeutic targets. Minocycline may affect craving, perhaps due to inhibition of nitric oxide (NO) formation, as NO acts as a second messenger for glutamate and dopamine receptors. NO also facilitates the effects of nicotine in the reward circuit, and blockade of NO has been demonstrated to eliminate nicotine abstinence symptoms in rats. A small study has demonstrated that minocycline reduces cigarette craving in human subjects without severe mental illness. The investigators will conduct a two-week randomized, double-blind, placebo-controlled, parallel group pilot study to investigate the effects of minocycline vs. placebo on craving and indicators of smoking intensity in smokers with schizophrenia. Participants will take minocycline up to 200 mg daily or matching placebo for two weeks. Participants will complete cigarette cue-elicited craving platforms and related assessments at baseline, and after 1 and 2 weeks of minocycline or placebo treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Tobacco Use

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minocycline
Arm Type
Experimental
Arm Description
Participants will take 50 mg minocycline capsules twice daily for 1 week, then take 100 mg capsules twice daily for 1 week.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will take capsules that match active drug, but contain no active ingredients, twice daily for week 1, and then will take capsules that match active drug, but contain no active ingredients, twice daily for week 2.
Intervention Type
Drug
Intervention Name(s)
Minocycline
Intervention Description
Minocycline capsules taken twice daily for two weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules taken twice daily for two weeks.
Primary Outcome Measure Information:
Title
Questionnaire for Smoking Urges-Brief
Description
This is a 10-item assessment used to measure craving to smoke and used in studies of smokers with schizophrenia. This scale has a score range from 0-100The change in QSU-Brief craving scores between time points (baseline to week 1, and baseline to week 2) will be assessed. The change in scores between the two timepoints will be calculated. The higher the score the stronger the urge to smoke is.
Time Frame
Baseline, Week 1, and Week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria DSM-IV or DSM-5 diagnosis of schizophrenia or schizoaffective disorder Male or Female Age: 18 to 65 years Caucasian or Non-Caucasian Smoke at least 10 cigarettes daily Urine cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3) Agrees to wear a head mounted display (HMD) for up to 45 minutes Able to complete the Evaluation to Sign Consent (ESC) with minimum score of 80% Exclusion Criteria History of organic brain disease DSM-IV diagnosis of Alcohol or Substance Dependence within the last six months (except nicotine) or DSM-5 diagnosis of Substance Use Disorder in the last six months (except nicotine) DSM-IV diagnosis of Alcohol or Substance Abuse within the last one month (except nicotine) or DSM-5 diagnosis of Substance Use Disorder in the last six months (except nicotine) Pregnancy or lactation Severe liver dysfunction (LFT 3X upper limit of normal) Previous known hypersensitivity to tetracyclines Current treatment with tetracycline or derivative Treatment with oral contraceptives (unless a second form of birth control is used and documented) Treatment with cholestyramine or colestipol Treatment with Urinary alkalinizers (e.g., sodium lactate, potassium citrate) Treatment with warfarin Treatment with bupropion, varenicline, or nicotine replacement products in the month prior to study inclusion Less than two months treatment of adjunctive medications AND less than one month on same dose: beta blockers, antidepressants, mood stabilizers, antianxiety medications. Medical condition whose pathology or treatment would significantly increase the risk associated with the proposed protocol. History of head injury, seizures, or stroke Positive urine toxicology screen for substances of non-therapeutic use prior to craving assessments
Facility Information:
Facility Name
Maryland Psyciatric Research Center
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This study was funded prior to the NIH requirements for sharing of IPD, therefore is not within our budget.

Learn more about this trial

Minocycline and Tobacco Craving in Smokers With Schizophrenia

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